CSRT.L Regulatory News (CSRT)

Consort Medical plc

27 October 2016

UCB CIMZIA® AutoClicks® prefilled pen launched in the UK

Consort Medical plc ("Consort Medical", "Consort" or the "Group") (LSE: CSRT), notes the announcement from UCB, dated 26 October 2016, that the new certolizumab pegol (Cimzia®) AutoClicks® prefilled pen is now available on the NHS following the recent positive opinion by the European Medicine's Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

This follows the EMA's CHMP decision recommending the use of Cimzia ® AutoClicks® prefilled pen in all approved indications, announced on 19 September 2016. The AutoClicks® prefilled pen is referred to as INJ570 in the Consort development portfolio.

Jon Glenn, Chief Executive Officer of Consort Medical, commented:

"We are delighted that the AutoClicks® prefilled pen autoinjector, which relies on Bespak technology at its core, has been launched in the UK market. This further significant milestone for the Bespak injectable franchise builds on the commercialisation of INJ300 for Dr. Reddy's Sumatriptan autoinjector in 2014 and the recent signing of the Syrina® autoinjector master development agreement, announced earlier this month."

The full text of the UCB announcement is reproduced below:

UCB announces availability of Cimzia AutoClicks Prefilled Pen on NHS in UK

Slough, England, Wednesday, October 26, 2016, 11:00 Hrs [IST]

UCB, a global biopharmaceutical company, announced that the new certolizumab pegol (Cimzia) AutoClicks Prefilled Pen is now available on the NHS following the recent positive opinion by the European Medicine's Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA's CHMP decision recommended the use of Cimzia AutoClicks Prefilled Pen in all approved indications (rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis [AS] and axial spondyloarthritis [axSpA]). The positive opinion was based on validated data and risk benefit analysis for the AutoClicks Prefilled Pen.

UCB is committed to providing value to patients and meeting their unique needs. As part of this commitment, UCB continued its partnership with OXO, a company known for thoughtful, consumer-friendly designs, to develop the AutoClicks Prefilled Pen, based on core technology licensed from Bespak. The AutoClicks Prefilled Pen provides a button-free delivery system and a wide non-slip grip that keeps patient hand disability in mind. It has a large viewing window that shows the progress of the injection and shows that they have administered it correctly with two clicks which indicate when the injection has started and when it has finished, giving patients the confidence to know they have received their full dose of certolizumab pegol.

Dr Ravik Mascarenhas, consultant rheumatologist at the Royal Devon & Exeter Foundation Trust said, "I see many patients whose joints have been destroyed by this painful disease so having a new choice is welcomed. Like most of us they also tend to find it a challenge self-injecting because of a needle - with this new pre-filled pen the patient doesn't even see the needle which may take some of the nerves and fear away."

In the UK the monthly cost to the NHS for treating a patient using the certolizumab pegol AutoClicks Prefilled Pen is £715 (2 treatments doses of 200mg).

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society, who was diagnosed with RA 30 years ago said, "It is difficult for people who do not suffer from this disease to understand just how challenging doing the ordinary things in daily life can be, more so for those with painful and swollen joints. Trying to grip an everyday object such as a kitchen gadget can cause immense pain. So we welcome any innovation that can help make the lives of RA patients more comfortable while they manage their condition."

Cimzia is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

In the EU, CImzia in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs); Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.

- ENDS -

Enquiries:

About Consort Medical

Consort Medical plc is a leading, global, single source drug and delivery device company (CDMO). We are at the leading edge of innovation and we are committed to investing in patient, clinician and customer driven innovation to create new treatments, new markets and new opportunities.

Our businesses

Bespak is a global market leader in the manufacture of drug delivery devices for pharmaceutical partner companies, including respiratory, nasal, and injectable products, and the manufacture of devices for the point of care diagnostics market. www.bespak.com.

Aesica is a leading provider of finished dose and active pharmaceutical ingredient (API) development and manufacturing services to pharmaceutical partners. www.aesica-pharma.com.

We employ more than 2000 people globally of which 1400 are located in the UK. We have UK facilities in King's Lynn, Cambridge, Nelson, Milton Keynes, Cramlington, Queenborough and Hemel Hempstead, German facilities in Monheim and Zwickau and a facility in Pianezza, Italy. Consort Medical is a public company quoted on the premium list of the London Stock Exchange (LSE: CSRT). www.consortmedical.com.

About AutoClicks® prefilled pen

The AutoClicks® prefilled pen is based on core technology licensed from Bespak, a Consort subsidiary and an established global market leader in the manufacture of drug delivery devices for pharmaceutical partner companies. The approval and launch of the AutoClicks® prefilled pen, referred to as INJ570 in the Consort development portfolio, follows the successful approval, launch, and commercialisation of INJ300 for Dr. Reddy's Sumatriptan autoinjector in 2014.

The AutoClicks® prefilled pen provides a button-free delivery system and a wide non-slip grip that keeps patient hand disability in mind. It has a large viewing window that shows the progress of the injection and shows that they have administered it correctly with two clicks which indicate when the injection has started and when it has finished, giving patients the confidence to know they have received their full dose of certolizumab pegol.

About CIMZIA®

CIMZIA® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

About CIMZIA® in the EU/EEA

In the EU, CIMZIA® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

CIMZIA® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.3

CIMZIA® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:4

· Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).

· Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4

For full safety and prescribing information please consult the document in the following link. European SmPC date of revision 17th December 2015.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

CIMZIA® is a registered trademark of the UCB Group of Companies.

REFERENCES

1. UCB. Data on file (Comparative Usability and Validation Study for CIMZIA® pre-filled pen - Study Report, Sections 8.2.1.1, 8.2.2.4, and 8.2.2.5). 2013.

2. Domanska B et al. Ann Rheum Dis. 2016;75(Suppl2):1002. Abstract AB0300

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news